The increased demand for more effective sharing of healthcare information to support complex patient pathways crossing organisational boundaries calls for semantic interoperable process-oriented Electronic Patient Record (EPR) systems. It follows the need for common standards to ensure that information is understood and interpreted consistently across various contexts.

A considerable body of literature has demonstrated that standardisation within healthcare has proven difficult to achieve. Moreover, standardisation processes have traditionally had a top-down approach, for which little attention has been paid to users’ work practices.

The many failures of standardisation efforts have put focus into alternative standardisation strategies, in which one promising method is promoted through the emerging openEHR approach for standardising the content of the EPRs. A network of voluntary clinical users should have a prominent role in standardisation processes and running the process in a distributed and negotiated manner over the Internet.

In this paper, we seek to give empirical insight regarding the evolving process of developing and implementing a sematic interoperable EPR system based on the openEHR framework, and the implication for organisation and governance addressed by the evolving process. We analyse the case through an information infrastructure perspective, and claim that user-driven standardisation of semantic interoperable EPR systems has to be supported by a multi-level organisational infrastructure, in addition to governance organisations that make decisions and monitor results and performances at different healthcare levels. The organisational and governance infrastructure has to be established simultaneously, but preferably, in advance of new development projects.

Empirically, we have followed the interplay between the developing process of an EPR system based on the openEHR approach and a government-led establishment of an archetype repository.